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The Future of BioPharma blog provides timely coverage of news that directly impacts the business strategies of the biotech, pharmaceutical and medical device industries. In addition to news coverage, the Future of BioPharma blog features live event coverage from IIR's Biopharmaceutical and Healthcare division.

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Monday, August 17, 2015

There is a trend within the
biopharmaceutical industry for companies to develop formulations for protein
drugs with extremely high concentrations. Such formulations provide advantages
to both patients and clinicians as they allow biological drugs to be delivered via
the sub-cutaneous route of administration rather than by the more traditional
intravenous route. Sub-cutaneous delivery allows patients to receive treatment in
a clinic or even administer the drug themselves while intravenous infusions
tend to require the patient to make a hospital visit which increases the cost
of treatment. However, if a patient is able to self-administer the
pharmaceutical drug they require to treat a chronic disease then they are more
able to lead a normal life which is a tremendous benefit (Highly concentrated protein formulations: Finding solutions for the next generation of parenteral biologics, J Kling, 2014).

The challenge of processing
highly concentrated protein drugs

Being able to provide a
biopharmaceutical at a formulated concentration of 100 g/L or higher can be a
means by which biopharmaceutical companies can gain an advantage over one
another in an increasingly competitive marketplace. However, developing such formulations
is no trivial task because at high concentrations, protein solutions can become
very viscous and difficult to process and the proteins themselves can
aggregate. The viscosity of these solutions can challenge filtration equipment
and can lead to significant yield losses in the final stages of the processes
when the product has its greatest value. Protein aggregation can lead to a
reduction in the pharmaceutical’s potency and can even trigger an immune
reaction to the drug.

Innovation at the interface
with formulationsThe topic of high
concentration protein formulations will be covered at the BioProcess International Conference & Exposition 2015 to be held on October 26-29 in Boston, MA.
Sigma S Mostafa, PhD, Director, Process Development at KBI Biopharma Inc will
be chairing a session on ‘Innovation at the Interface with Formulations’.
Pfizer are scheduled to present on ‘Challenges of High Concentration
Formulations – Dealing with Viscosity and Excipients’ while Mark Moody will
present on ‘Opportunities and Challenges of High Concentration Biologics: Case
Studies’. The session promises to address some of the key issues manufacturers
face when processing concentrated protein solutions.

Have your say

Protein biopharmaceuticals are
being formulated to 100 g/L even 200 g/L, however, some have proposed that
concentrating to 500 g/L may be desirable. In your opinion, what is the maximum
concentration that is required or attainable for protein drug formulations?

Dr Nick Hutchinson has a Masters and Doctorate in
Biochemical Engineering from University College London, UK where he focused on
laboratory tools for rapid bioprocess development and characterization. He then
worked at Lonza Biologics in an R&D function investigating novel methods
for large-scale antibody purification before moving to an operational role
scaling-up and transferring manufacturing processes between Lonza sites in the
UK, Spain and USA. Nick now works in Market Development at Parker domnick
hunter where his focus is in bringing Parker's strengths in Motion &
Control to Bioprocessing. This will enable customers to improve the quality and
deliverability of existing and future biopharmaceuticals.

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